Biogen Sr Associate I, IT Quality in Cambridge, Massachusetts
The Sr Associate I, IT Quality will review and approve system life cycle deliverables (SDLC) and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities Foundational and executable regulatory expectations for CS. Works with peers locally and globally, when necessary to ensure practices are consistent with requirements and expectations set forth within the governing QMS.
Represent ITQ on cross-functional teams in support of SDLC activities for GxP applications, Drive the deployment of new or modified GxP systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.
Support the compliant implementation of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns to industry as well as Biogen expectations. Support globally as ITQ representative.
Support all Global Quality initiatives, including Data Integrity, Computerized Systems and IT QMS implementation / remediation.
Provide quality assurance oversight for system related issues (deviations, incidents, etc.) and application change controls
Support GxP audit readiness activities. Assist with internal and external audits/inspections.
Minimally BA/BS in Engineering, Life Sciences, or IT related discipline with 3+ years of relevant industry experience required.
Ability to interpret regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation.
Depth of understanding of respective regulations governing computer systems and controls such as FDA’s 21 CFR Part 11, EMA’s Annex 11, and MHRA’s data integrity guidance.
Understanding of risk-based methodologies as it relates to qualification and validation.
Knowledge of underlying infrastructure requirements supporting GxP systems.
Understanding of risk-based methodologies as it relates to qualification and validation
Strong communication skills
As part of the IT Quality team, deliver technically robust and compliant GxP computerized systems (CS) on cross-functional teams in support of SDLC activities.